The Results of the Mediterranean Diet for PCOS

Last updated: November 16, 2024
Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Overall Status: Completed

Phase

N/A

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Treatment

Mediterranean Diet

Clinical Study ID

NCT06442189
01/06 22.01.2024
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study Summary

The aim was to evaluate the effects of the application of a Mediterranean diet on the reproductive and metabolic parameters in the 3rd month in patients with a body mass index of 25 and more who were followed up in our clinic due to a PCOS diagnosis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At the age of 18-40 years,

  • No underlying metabolic disease (type 2 diabetes, hypertension, diagnosed anemia),

  • With a body mass index of 25 and above,

  • Female patients attending the PCOS clinic and under the care of our hospital'sdietitian will be enrolled in the study.

Exclusion

Exclusion Criteria:

  1. Age < 18 and > 40 years;

  2. Menopause, pregnancy or breastfeeding in the last 6 months;

  3. Hyperandrogenism and/or biochemical hyperandrogenemia due to secondary etiologies,including congenital adrenal hyperplasia, androgen-secreting tumors, Cushing'ssyndrome, hyperprolactinemia, thyroid dysfunction and adrenal disorders),

  4. Pre-existing systemic or psychiatric disease

  5. Use of drugs that affect carbohydrate or lipid metabolism (oral contraceptive pills,metformin, anti-epileptics, antipsychotics, statins and fish oil);

  6. Certain eating regimens or hypocaloric diet in the last three months; supplementingwith antioxidants, vitamins or minerals;

  7. Non-steroidal anti-inflammatory drugs, diuretics, etc. use of medications that mayaffect fluid balance

  8. Female patients with implanted pacemakers or defibrillators due to the theoreticalpossibility of interference with device activity.

Study Design

Total Participants: 98
Treatment Group(s): 1
Primary Treatment: Mediterranean Diet
Phase:
Study Start date:
September 20, 2024
Estimated Completion Date:
November 11, 2024

Study Description

Polycystic ovary syndrome (PCOS) is an endocrine-metabolic disorder characterized by menstrual irregularities, anovulation, clinical and/or biochemical symptoms of hyperandrogenism (hirsutism and/or acne), micropolycystic ovaries and metabolic abnormalities. Phenotype A: HA + OD + PCOM; phenotype B: HA + OD; phenotype C: HA + PCOM and phenotype D: OD + PCOM). According to the Rotterdam criteria, endocrine and metabolic abnormalities are lowest in the OD + PCOM group among these 4 different phenotype groups. The prevalence and distribution of metabolic abnormalities (insulin resistance, metabolic disease and glucose intolerance) among the phenotypes do not differ significantly between the 4 groups. Therefore, metabolic abnormalities and distribution characteristics are not suitable to distinguish different clinical PCOS phenotypes. Some inflammatory cytokines are elevated in PCOS, which is characterized by chronic low-grade inflammation. Although the exact mechanisms of inflammation in PCOS are not yet fully understood, it is thought to be mediated by obesity, insulin resistance and high androgen levels. This inflammatory state has a negative impact on the risk of future health problems and quality of life in PCOS. Therefore, strategies to reduce inflammation are considered important. Establishing medical nutrition therapy for PCOS has significant implications for reducing this inflammation and preventing the disease. At this point, the Mediterranean diet, which has been shown to have a protective effect against many diseases, is receiving a lot of attention. Among the components of the Mediterranean diet, omega-3 fatty acids, antioxidants and fiber in particular can contribute to reducing inflammation through various mechanisms. The international scientific community has strongly emphasized the role of the Mediterranean diet and the lifestyle it inspires in increasing life expectancy and improving public health. For these reasons, the Mediterranean diet can be considered as a nutrient pool containing nutraceuticals and bioactive components in foods that can positively influence health both directly and through their own epigenetic mechanisms. Recent studies suggest that the Mediterranean diet can influence both the incidence and severity of PCOS and the treatment of the disease.

The main objective of our study is to evaluate the effect of the MedDiet, which is known to be anti-inflammatory and based on energy restriction and the Mediterranean dietary approach, on the reproductive and metabolic parameters of PCOS patients with a higher than normal body mass index.

Connect with a study center

  • Etlik Zübeyde Hanım

    Ankara, 06000
    Turkey

    Site Not Available

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